Trial Outcomes & Findings for Heart Rate Response to Regadenoson and Sudden Cardiac Death (NCT NCT01842035)

NCT ID: NCT01842035

Last Updated: 2022-10-18

Results Overview

Sudden cardiac death will be defined as death within 1 hour of symptom onset, or an unobserved death in which the patient was seen and known to be doing well within 24 hours of death. Survivors of aborted sudden cardiac death, resuscitated cardiac arrest, and those receiving appropriate ICD therapy will also be considered to have experienced sudden cardiac death and will be included in the primary end point.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 90 participants
• Primary outcome timeframe: Until end of follow-up, median follow-up 40 months
• Results posted on: 2022-10-18

Participant Flow

Participant milestones

Measure	Regadenoson Prior to the implantation of a clinically indicated ICD, the heart rate response to regadenoson will be assessed. Regadenoson will be administered intravenously as a fixed intravenous bolus dose of 400 μg followed by a 5 mL saline flush. Medications (including beta-blockers) will be withheld on the morning of the test. The heart rate and blood pressure will be measured at baseline and every minute after regadenoson bolus for at least 5 minutes and until the heart rate and blood pressure are clearly returning towards baseline. \-------------------------------------------------------------------------------- regadenoson: Prior to the implantation of a clinically indicated ICD, the heart rate response to regadenoson will be assessed. Regadenoson will be administered intravenously as a fixed intravenous bolus dose of 400 μg followed by a 5 mL saline flush. Medications (including beta-blockers) will be withheld on the morning of the test. The heart rate and blood pressure will be measured at baseline and every minute after regadenoson bolus for at least 5 minutes and until the heart rate and blood pressure are clearly returning towards baseline.
Overall Study STARTED	90
Overall Study COMPLETED	90
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Heart Rate Response to Regadenoson and Sudden Cardiac Death

Baseline characteristics by cohort

Measure	Regadenoson n=90 Participants Prior to the implantation of a clinically indicated ICD, the heart rate response to regadenoson will be assessed. Regadenoson will be administered intravenously as a fixed intravenous bolus dose of 400 μg followed by a 5 mL saline flush. Medications (including beta-blockers) will be withheld on the morning of the test. The heart rate and blood pressure will be measured at baseline and every minute after regadenoson bolus for at least 5 minutes and until the heart rate and blood pressure are clearly returning towards baseline. \-------------------------------------------------------------------------------- regadenoson: Prior to the implantation of a clinically indicated ICD, the heart rate response to regadenoson will be assessed. Regadenoson will be administered intravenously as a fixed intravenous bolus dose of 400 μg followed by a 5 mL saline flush. Medications (including beta-blockers) will be withheld on the morning of the test. The heart rate and blood pressure will be measured at baseline and every minute after regadenoson bolus for at least 5 minutes and until the heart rate and blood pressure are clearly returning towards baseline.
Age, Continuous	60 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants
Sex: Female, Male Male	54 Participants n=5 Participants
Race/Ethnicity, Customized Black	36 Participants n=5 Participants
Race/Ethnicity, Customized White	54 Participants n=5 Participants
Region of Enrollment United States	90 participants n=5 Participants

PRIMARY outcome

Timeframe: Until end of follow-up, median follow-up 40 months

Sudden cardiac death will be defined as death within 1 hour of symptom onset, or an unobserved death in which the patient was seen and known to be doing well within 24 hours of death. Survivors of aborted sudden cardiac death, resuscitated cardiac arrest, and those receiving appropriate ICD therapy will also be considered to have experienced sudden cardiac death and will be included in the primary end point.

Outcome measures

Measure	Heart Rate Response Greater Than Median n=44 Participants Heart rate response \>= 24%	Heart Rate Response Less Than Median n=46 Participants Heart rate response \< 24%
Sudden Cardiac Death	2 Participants	6 Participants

SECONDARY outcome

Timeframe: Until end of follow-up, median follow-up 40 months

death from any cause

Outcome measures

Measure	Heart Rate Response Greater Than Median n=44 Participants Heart rate response \>= 24%	Heart Rate Response Less Than Median n=46 Participants Heart rate response \< 24%
All-cause Death	8 Participants	8 Participants

SECONDARY outcome

Timeframe: Until end of follow-up, median follow-up 40 months

antitachycardia pacing therapy or shock for tachyarrhythmia determined by evaluation of the clinical information and by device diagnostics to be either ventricular fibrillation or ventricular tachycardia

Outcome measures

Measure	Heart Rate Response Greater Than Median n=44 Participants Heart rate response \>= 24%	Heart Rate Response Less Than Median n=46 Participants Heart rate response \< 24%
First Appropriate ICD Therapy	6 Participants	12 Participants

SECONDARY outcome

Timeframe: Until end of follow-up, median follow-up 40 months

unnecessary antitachycardia pacing or shock delivered by the ICD for a rhythm that is not a true ventricular fibrillation or ventricular tachycardia

Outcome measures

Measure	Heart Rate Response Greater Than Median n=44 Participants Heart rate response \>= 24%	Heart Rate Response Less Than Median n=46 Participants Heart rate response \< 24%
Inappropriate ICD Therapy	3 Participants	2 Participants

SECONDARY outcome

Timeframe: Until end of follow-up, median follow-up 40 months

death or antitachycardia pacing therapy or shock for tachyarrhythmia determined by evaluation of the clinical information and by device diagnostics to be either ventricular fibrillation or ventricular tachycardia

Outcome measures

Measure	Heart Rate Response Greater Than Median n=44 Participants Heart rate response \>= 24%	Heart Rate Response Less Than Median n=46 Participants Heart rate response \< 24%
All-cause Death or First Appropriate ICD Therapy	13 Participants	16 Participants

SECONDARY outcome

Timeframe: Until end of follow-up, median follow-up 40 months

Sudden cardiac death or antitachycardia pacing therapy or shock for tachyarrhythmia determined by evaluation of the clinical information and by device diagnostics to be either ventricular fibrillation or ventricular tachycardia

Outcome measures

Measure	Heart Rate Response Greater Than Median n=44 Participants Heart rate response \>= 24%	Heart Rate Response Less Than Median n=46 Participants Heart rate response \< 24%
Sudden Cardiac Death or Appropriate ICD Therapy	8 Participants	15 Participants

Adverse Events

Regadenoson

Serious events: 0 serious events

Other events: 24 other events

Deaths: 16 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Regadenoson n=90 participants at risk Prior to the implantation of a clinically indicated ICD, the heart rate response to regadenoson will be assessed. Regadenoson will be administered intravenously as a fixed intravenous bolus dose of 400 μg followed by a 5 mL saline flush. Medications (including beta-blockers) will be withheld on the morning of the test. The heart rate and blood pressure will be measured at baseline and every minute after regadenoson bolus for at least 5 minutes and until the heart rate and blood pressure are clearly returning towards baseline. \-------------------------------------------------------------------------------- regadenoson: Prior to the implantation of a clinically indicated ICD, the heart rate response to regadenoson will be assessed. Regadenoson will be administered intravenously as a fixed intravenous bolus dose of 400 μg followed by a 5 mL saline flush. Medications (including beta-blockers) will be withheld on the morning of the test. The heart rate and blood pressure will be measured at baseline and every minute after regadenoson bolus for at least 5 minutes and until the heart rate and blood pressure are clearly returning towards baseline.
Vascular disorders symptomatic hypotension	0.00% 0/90 • Adverse Events were monitored for 1 day and deaths were monitored until end of follow-up, median of 40 months Adverse events were monitored for 1 day while outcomes were monitored until end of follow-up.
Respiratory, thoracic and mediastinal disorders bronchospasm	0.00% 0/90 • Adverse Events were monitored for 1 day and deaths were monitored until end of follow-up, median of 40 months Adverse events were monitored for 1 day while outcomes were monitored until end of follow-up.
Skin and subcutaneous tissue disorders flushing	12.2% 11/90 • Number of events 11 • Adverse Events were monitored for 1 day and deaths were monitored until end of follow-up, median of 40 months Adverse events were monitored for 1 day while outcomes were monitored until end of follow-up.
Cardiac disorders chest pain	1.1% 1/90 • Adverse Events were monitored for 1 day and deaths were monitored until end of follow-up, median of 40 months Adverse events were monitored for 1 day while outcomes were monitored until end of follow-up.
Respiratory, thoracic and mediastinal disorders shortness of breath	15.6% 14/90 • Number of events 14 • Adverse Events were monitored for 1 day and deaths were monitored until end of follow-up, median of 40 months Adverse events were monitored for 1 day while outcomes were monitored until end of follow-up.
Gastrointestinal disorders Gastrointestinal symptoms	10.0% 9/90 • Number of events 9 • Adverse Events were monitored for 1 day and deaths were monitored until end of follow-up, median of 40 months Adverse events were monitored for 1 day while outcomes were monitored until end of follow-up.
Cardiac disorders Ventricular tachycardia	0.00% 0/90 • Adverse Events were monitored for 1 day and deaths were monitored until end of follow-up, median of 40 months Adverse events were monitored for 1 day while outcomes were monitored until end of follow-up.

Additional Information

Fadi Hage

University of Alabama at Birmingham

Phone: 2059757123

Email: fadihage@uab.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place